# K030739: Infusion Dynamics (ID) Power Infuser, Model M100B-3A with Blood Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Infusion Dynamics, Inc.
- Decided: Jan 14, 2004 after 310 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090736: Power Infuser, Model M100B-3A (2009), 1 descendant of its own
- K172653: Power Infuser (2018), 0 descendants of its own

## Recalls of this device
- Sep 21, 2004 · Not classified · Z-0062-05: Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position.

## Indications for use
The ID Power Infuser® Model M001B-3A is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock. The device is intended for use by medical, paramedical, and EMT personnel in the field and in pre-hospital and hospital environments. When used with the CrystalloidlColloid Cartridge (K992044), the ID Power Infuser® Model M100B-3A is intended to deliver crystalloid and colloid resuscitative fluids only. This cartridge is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge, the ID Power Infuser® Model M100B-3A is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood-cells. The ID Power Infuser® Model M100B-3A is not intended to support the delivery of any pharmaceutical or other medications.

Source page: https://510kreport.com/device/K030739
Methodology: https://510kreport.com/methodology